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CTRI Number  CTRI/2015/08/006100 [Registered on: 17/08/2015] Trial Registered Retrospectively
Last Modified On: 13/08/2015
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Biological
Surgical/Anesthesia
Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Extraction socket preservation procedure using platelet rich fibrin with and without calcium phosphate cement 
Scientific Title of Study   Comparative evaluation of socket preservation procedure using platelet rich fibrin with and without calcium phosphate cement– A Clinico-Radiographic Study. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Nihal Devkar 
Designation  Reader 
Affiliation  Sinhgad Dental College and Hospital, Pune 
Address  Sinhgad Dental College and Hospital, Vadgaon Budruk, Off Sinhgad Road, Pune

Pune
MAHARASHTRA
411041
India 
Phone    
Fax    
Email  drdevkar@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shwetambari Navale 
Designation  P.G Student 
Affiliation  Sinhgad Dental College and Hospital, Pune 
Address  Sinhgad Dental College and Hospital, Vadgaon Budruk, Off Sinhgad Road, Pune

Pune
MAHARASHTRA
411041
India 
Phone    
Fax    
Email  shweta2747@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Nihal Devkar 
Designation  Reader 
Affiliation  Sinhgad Dental College and Hospital, Pune 
Address  Sinhgad Dental College and Hospital, Vadgaon Budruk, Off Sinhgad Road, Pune

Pune
MAHARASHTRA
411041
India 
Phone    
Fax    
Email  drdevkar@gmail.com  
 
Source of Monetary or Material Support  
IFGL REFRACTORIES LTD. Unit 1 sector A kalunga industrial estate, Kalunga-770031 dist: sundergarh, Odisha 
 
Primary Sponsor  
Name  Sinhgad Dental College and Hospital 
Address  Dept of Periodontology, Room No.4, Vadgaon Budruk, Off Sinhgad Road, Pune 411041 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Nihal Devkar  Sinhgad Dental College and hospital  Department of periodontology, Room No.4, Vadgaon Budruk, Off Sinhgad Road, Pune
Pune
MAHARASHTRA 
9420481441

drdevkar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sinhgad Dental College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Systemically healthy patients between the age group 20-45 years having at least two non-molar teeth indicated for extraction.,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Calcium phosphate Cement  Calcium phosphate cement, dose-0.5cc Route-direct delivery to the extraction site assessment duration-6 months 
Comparator Agent  platelet rich fibrin  platelet rich fibrin autologous, obtained from a dose of 10 ml intravenous blood, Route- direct delivery to the extraction site. assessment duration- 6 months 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  Systemically healthy patients between the age group 20- 45 years
Patients having at least two non-molar teeth indicated for extraction.
Indications for extraction include either root fracture, endodontic treatment failure, or non-restorable carious teeth.
Alveolar sockets with 4 wall architecture.
Patients willing to participate and sign an informed consent. 
 
ExclusionCriteria 
Details  Patients who are systemically compromised.
Patients having history of smoking or tobacco habit.
Patients on medications that impair hematological parameter.
Patient having history of bone disorder.
Teeth having acute periapical or periodontal pathology.
Pregnant and lactating females.
Extraction sockets with one or more bony walls damaged. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Centralized 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Clinical and Radiographic of
a. Marginal bone levels, calculated using a Williams periodontal probe as the distances between the coronal border of the stent and the mid-buccal and the mid-palatal aspect of the alveolar bone crest.
b. The bucco-palatal width will be measured using a surgical caliper at mid-buccal and mid-palatal aspect of the socket at 1mm, 3mm and 5mm apical to the bone crest.
Time point-at 6 months 

Time point-at 6 months
 
 
Secondary Outcome  
Outcome  TimePoints 
none  none 
 
Target Sample Size   Total Sample Size="15"
Sample Size from India="15" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   03/02/2014 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   1. Orgeas GV, Clementini M, Risi VD, Sanctis Md. Surgical techniques for alveolar socket preservation: A systemic review. Int J Oral Maxillofac Implants 2013;28:1049-10. 2. Aimetti M, Romano F, Griga FB, Godia L. Clinical and histological healing of human extraction sockets filled with calcium sulphate. Int J Oral Maxillofac Implants 2009;24:901-909. 3. Behnam Shakibaie-M. Comparison of the effectiveness of two different bone substitute materials for socket preservation after tooth extraction: A controlled clinical study. Int J Periodontics Restorative Dent 2013;33:223-228. 4. Darby I, Chen ST, Buser D. Ridge preservation techniques for implant therapy. Int J Oral Maxillofac Implants 2009;24:260-271. 5. Horowitz R, Holtzclaw D, Rosen PS. A review on alveolar ridge preservation following tooth extraction. J Evid Base Dent Pract 2012; SI: 149-1  
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

After extraction, severe hard and soft tissue alteration takes place within the affected site of alveolar ridge.1 The three dimensional resorption process at extraction sites results in narrower ridges and reduced vertical height and lingual/palatal shifting of their long axis. Most of the dimensional alterations take place in the first 3 months following tooth removal.2   

 

In the first 12 months after extraction, the height of alveolar ridge can diminish upto 50% because the alveolar bone resorbs especially on the buccal aspect.3  This change may lead to esthetic and functional disadvantages that compromise future implant placement particularly if the dental implant placement needs to be delayed for 6 months or longer.

 

Hence it is crucial to preserve the dimensions and contour of the alveolar ridge after tooth extraction to achieve a predictable esthetic and functional prosthetic restoration.

Preservation of the residual alveolar socket at the time of tooth extraction has been evaluated in many studies.  Clinical, histologic and radiographic studies documented positive socket healing responses with autogenous bone, alloplasts and xenografts, whereas others reported poor results with bovine bone, decalcified freeze dried bone & autogenous bone.1, 4, 5, 6, 7, 8

 

Since they are associated with varying amounts of vital bone socket fill, comparison studies are useful to determine the amount of socket preservation that occurs with each material. A new class of alloplast materials, namely, calcium phosphate cements (CPC) raised certain hopes in periodontal repair in the early 1990s.  These are aqueous based cements that get converted to hydroxyapatite upon setting.  The combination of biocompatibility, osteoconductivity and restorability makes it a unique material for grafting bony defects.9

 

Platelet rich fibrin (PRF) is an autologous preparation of concentrated platelets created by centrifugation of a patient’s blood.  The use of PRF during surgical procedure is a current treatment concept used to accelerate wound healing and tissue maturation.  It can be used directly as a clot or after compression as a strong membrane. 10  

 

Based on these positive findings of calcium phosphate cement and platelet rich fibrin, the purpose of this study is to compare clinical and radiographic [Cone Beam Computed Tomography (CBCT)] outcomes following grafting for post extraction ridge preservation in sites treated with platelet rich fibrin with or without calcium phosphate cement.

Aim:

To compare the use of platelet rich fibrin (PRF) with and without calcium phosphate cement in fresh extraction sockets by clinical and radiographic analyses.

 

Objectives:

1.  To evaluate horizontal and vertical ridge changes associated with PRF used with and without CPC at baseline and after 6 months using clinical and radiographic methods.

2.  To compare horizontal and vertical ridge changes associated with PRF used with and without CPC using clinical and radiographic methods.

3.  To evaluate and compare the radiographic density changes associated with PRF used with and without CPC.

 
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